At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 723 enrolled
Drug / intervention
Axitinib (AG-013736) +1 moredrug
Likely dose
Axitinib (AG-013736) 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL
In Brief
A Phase 3 clinical trial evaluating Axitinib (AG-013736) and Sorafenib for Kidney Neoplasms. Completed, enrolled 723 participants across 294 sites in 22 countries.
Detailed Summary
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Neoplasms
CountriesAustralia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Ireland, Italy, Japan, Poland, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2008
Enrollment StartSep 2008
Primary CompletionAug 2010
Study CompletionFeb 2016
TodayJul 2026
First PostedMay 15, 2008
Enrollment StartSep 3, 2008
Primary CompletionAug 31, 2010
Study CompletionFeb 25, 2016
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 18.1 years ago
Interventions
Axitinib (AG-013736)drug
axitinib will be given at a starting dose of 5 mg twice daily \[BID\] with continuous dosing
Sorafenibdrug
sorafenib will be given at a dose of 400 mg twice daily \[BID\] with continuous dosing